The U.S. Food and Drug Administration issued a draft guidance
today describing its intent to exercise enforcement discretion with
respect to the premarket notification requirements for certain in
vitro diagnostic and radiology devices with well-established safety
and effectiveness profiles.

The draft guidance lists 30 different device types, including
common urine and blood tests, alcohol breath tests, blood clotting
protein tests, and radiology device accessories, such as film
cassettes, film processors, and digitizers. FDA intends to
exempt these devices from premarket notification requirements
through the appropriate regulatory processes. In the meantime,
however, FDA does not intend to enforce the premarket notification
requirements with respect to these devices provided that they do
not exceed the limitations on exemption specified in the device
classification regulations.

FDA intends to continue to enforce all other applicable
requirements, including, but not limited to, registration and
listing and Good Manufacturing Practices as set forth in the
Quality System regulations.

“The safety and effectiveness of these devices have been
well demonstrated over the years,” said Jeffrey Shuren, M.D.,
director of FDA’s Center for Devices and Radiological Health.
“By addressing the risk level of these devices, the agency is
taking a smart regulatory approach that eases unnecessary
requirements for manufacturers, while making sure the public has
safe and effective devices.”

The device types listed in the draft guidance include devices
identified by the FDA as those for which less stringent oversight
would not compromise public health.

The FDA is seeking further comment on the draft guidance from
manufacturing, clinical and patient communities. The draft guidance
is open for comment for 90 days.

In the future, the FDA also intends to reduce the pre-market
regulatory burden on additional in vitro diagnostic and radiology
device types.

The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating
tobacco products.